Steroid drugs such as prednisone taken by 25.5 million Americans for arthritis, cancer, transplants and other conditions need stronger consumer warnings about a rare but possibly irreversible vision impairment, USA Today reported. A University of Michigan eye doctor and the consumer Public Citizen organization advocated for stronger warning labels on the drugs at a federal petition.
The problem, chorioretinopathy, which causes distortion in vision, is not well known to doctors, U-M’s Jonathan Trobe says. Given the number of people who take the drugs, “it’s useful to know that a lot of visual complications are associated with steroids and if people develop a problem they should see an eyecare specialist,” says Trobe, professor of ophthalmology and neurology at U-M. Trobe joined the nonprofit Washington, D.C., organization in calling for stronger and more consistent warnings about the drugs.
Known generically as glucocorticosteriods, the medicines have been on the market for decades. Only two manufacturers of more than a dozen list the complication on drug labels as a potential side effect, said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. The problem may go away on its own but can come back and lead to permanent visual loss, particularly in the center of the eye, Carome says.
The federal Food and Drug Administration lists petitions on its web site, www.regulations.gov, typically within a few weeks after a petition is filed, and invites the public to comment on the proposal. The Public Citizen web site, www.citizen.org, has copies of the petition. A spokesman for the Generic Pharmaceutical Association, a trade organization representing generic manufacturers, says the group would “defer to the FDA’s judgment” on whether a review of generic labels is needed.
